Duns Number:040729840
Device Description: NITINOL K WIRE TROCAR PIN 500MM X 1.5MM
Catalog Number
-
Brand Name
NITINOL K WIRE TROCAR PIN
Version/Model Number
1106-721
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2018
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100736
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
f2b84414-e749-4bc2-ae0d-ca831a027189
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |